To apply for Class C medical device registration with the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, you will need to follow these steps and use the SFDA GHAD system for submission.

Steps to Apply for Class C Medical Device SFDA Registration

1. Appoint a Saudi Authorized Representative (AR)

   • Non-Saudi manufacturers must appoint a Saudi-based Authorized Representative (AR) who holds a valid SFDA Medical Device Establishment License (MDEL).
   • The AR will handle the application process, including submission and communication with the SFDA.

2. Prepare Required Documentation

   • Compile all necessary documents for the registration, including:
     • Technical File: Device description, design and manufacturing details, risk management file, clinical evaluation, testing reports.
     • Quality Management System (QMS) Certification: Typically ISO 13485.
     • Labeling and Instructions for Use (IFU): Must be in both Arabic and English.
     • Declaration of Conformity: Manufacturer’s statement of compliance with relevant standards.
     • Post-Market Surveillance Plan: How the device's safety and effectiveness will be monitored after it’s on the market.
     • Regulatory Approvals from Other Jurisdictions (if applicable): Such as CE Marking or FDA clearance.

3. Register on the SFDA GHAD Portal

   • Visit the GHAD portal: SFDA GHAD System
   • Create an account if you don’t already have one.
   • Both the manufacturer and the AR need to be registered on the GHAD system.

4. Submit the Medical Device Marketing Authorization (MDMA) Application

   • Log into the GHAD system and start a new application for Medical Device Marketing Authorization (MDMA).
   • Complete the online application form and upload all required documents.

5. Pay Registration Fees

   • Pay the applicable registration fees through the GHAD system. The fee amount will be displayed during the application process and will vary based on the device and its classification.

6. Track and Respond to Application Status

   • After submission, you can track the status of your application through the GHAD portal.
   • Be prepared to respond promptly to any requests for additional information or clarifications from the SFDA.

7. Receive and Comply with SFDA Approval

   • Once the application is approved, the SFDA will issue a Medical Device Marketing Authorization (MDMA).
   • Comply with post-market obligations such as adverse event reporting and maintaining the device's safety and effectiveness.

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